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Completed

NCT Number: NCT04446754

The Genetic Effects of rs7903146 and Dietary Intake on Type 2 Diabetes Mellitus Risk in a Healthy Population

This study investigates the association of genetic effects of rs7903146 and dietary intake on type 2 Diabetes Mellitus (T2DM) risk in a healthy population. T2DM risk was assessed through glycated haemoglobin (HbA1c) concentration in 73 subjects. Dietary intake was assessed using a validated food frequency questionnaire (FFQ).

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Marys University

London, TW1 4SX, United Kingdom

About this study

Type 2 diabetes mellitus (T2DM) is a global epidemic linked to 1.6 million deaths in 2016. Diet, lifestyle and environment contribute significantly to T2DM-risk. Genome-wide association studies identify the transcription factor 7-like 2 (TCF7L2) rs7903146 (C/T) gene as one of the most important associated with T2DM-risk. The T-allele is associated with a two-fold increase in relative risk of T2DM across different populations. However, most studies associating genetic effects of dietary intake on rs7903146 and T2DM-risk utilised volatile instantaneous measures of glucose(5) and focussed on individual macronutrients. Understanding the association of rs7903146 and overall macronutrient intake using a stable blood homeostasis marker may provide a fuller insight into T2DM-risk.

The study included data for all variables (participant characteristics: sex (female/male), age (years), height (cm), weight (kg), body mass index (BMI) (kg/m2), body fat percentage (%), fat mass (kg), lean mass (kg), waist/hip (ratio), dietary intake, HbA1c (mmol/mol and %) and physical activity (hours/week). All data was collected at St Mary's University between April to July 2019. Participants was genotyped and allocated into two groups: major allele (C) homozygote versus minor allele (T) homozygote plus heterozygote. T2DM-risk was assessed through their value of HbA1c and participants were classified as follows: normal (<42mmol/mol/ <6.0%), pre-diabetic (42 to 47 mmol/mol/ 6.0% to 6.4%), diabetes (48mmol/mol /6.5% or over).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Eligibility criteria required healthy adults free from metabolic condition and free from medication affecting glycated haemoglobin levels.

Exclusion criteria

Individuals with HbA1c levels ≥48 mmol/mol or ≥6.5% were excluded due to a classification as T2DM (WHO, 2011).

Treatment and study plan

Primary outcomes

  1. DNA

    Time frame: 3 months

    salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)

  2. Hba1c

    Time frame: 3 months

    capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG & C0., Nümbrecht, Germany)

  3. Diet intake

    Time frame: 3 months

    Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)

Secondary outcomes

  1. Body weight

    Time frame: 3 months

    Body weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset

  2. Waist

    Time frame: 3 months

    Waist measurement was taken midway between iliac crest and lowest rib

  3. Hip

    Time frame: 3 months

    Hip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)

  4. Height

    Time frame: 3 months

    Subject height was recorded to the nearest 0.1-cm via stadiometer

  5. Physical activity

    Time frame: 3 months

    Assessed through Physical Activity Readiness Questionnaire (PAR-Q)

  6. Fat mass

    Time frame: 3 months

    Measured in kg and percentage (%) measured by bioelectrical impedance analysis

  7. Lean mass

    Time frame: 3 months

    Measured in kg and percentage (%) measured by bioelectrical impedance analysis

Sponsors and collaborators

Lead sponsor

St Mary's University College

Other

Registry information

Official study title

The Association Between TCF7L2 rs7903146, Diet and Type 2 Diabetes Mellitus Risk

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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